CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
Regard Dressing Change Tray recalled by ROi CPS
ROi CPS is recalling Regard Dressing Change Tray, distributed nationwide in the US. The recall was initiated on 26 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1542-2021
- FDA event ID
- 87658
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2021
- FDA classified
- 7 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2021 | Recall initiated by company | |
| 7 May 2021 | Classified by FDA | +42 days |
| 19 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Regard Dressing Change Tray
Where it was distributed
US Nationwide distribution in the state of Louisiana.
Questions about this recall
Is Regard Dressing Change Tray recalled?
Yes. ROi CPS recalled Regard Dressing Change Tray on 26 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1542-2021.
Why was it recalled?
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Which lots are affected?
Lot Numbers: 86983C, 87081C and 86356C.
Where was it sold?
US Nationwide distribution in the state of Louisiana.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ROi CPS
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled | ROi CPS | Potency & Assay | MO |
| Device | CLASS II | regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled | ROi CPS | Packaging Defects | Nationwide |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
| Device | CLASS I | regard Operative LAP recalled by ROi CPS | ROi CPS | Other | LA |
| Device | CLASS I | Regard Dressing change kit recalled by ROi CPS | ROi CPS | Other | Nationwide |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |